A Clinical Study With Aliskiren Alone or in Combination Therapy With Diuretic Hctz in Venezuelan Hypertensive Patients.

A 16-week, Prospective, Open Label, Multicenter Study to Evaluate the Effectiveness and Safety of Rasilez® (Aliskiren) Monotherapy or in Addition With Hydrochlorothiazide 12.5 mg or 25 mg in Patients With Hypertension Stage I and II

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01056731

Acronym

ANDROMEDA

Enrollment

253

Registered

2010-01-26

Start date

2010-02-28

Completion date

2011-10-31

Last updated

2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Blood Pressure

Keywords

high blood pressure, aliskiren, hydrochlorothiazide, control rate

Brief summary

This is an open-label, not controlled, sequential, dose escalation study of 16 weeks' duration. The study is composed of two periods: a 0-2 week optional wash-out period depending on previous antihypertensive treatment(s), followed by a 16-week open-label active treatment period. Patients will be evaluated every 4 weeks during period 2. Treatment will start with Aliskiren 150 mg with dose titration to Aliskiren 300 mg, and addition of HCTZ 12,5 mg and 25 if control of BP is not achieved (\< 140/90 mmHg or 130/ 80 mmHg in diabetics patients). All patients who have reached their BP target will be considered as having met the primary endpoint and this visit will be considered as the final visit.

Interventions

DRUGAliskiren and HCTZ

Aliskiren 150 mg and 300 mg Hydrochlorothiazide 12.5 mg and 25 mg

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Outpatients, with essential hypertension, stage I-II, naïve or not controlled with monotherapy.

Exclusion criteria

* BP\> 180/110 mmHg * Pregnant or nursing women * Hypertensive encephalopathy or cerebrovascular accident, transient ischemic - cerebral attack, myocardial infarction, unstable angina, coronary bypass surgery, percutaneous coronary intervention within 6 month * K \<3.5 mEq/L or ≥ 5 mEq/L * Renal impairment * Hypersensitivity to HCTZ or Aliskiren or angioedema due to ACE-I or ARB * Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
The proportion of patients in whom BP control was achieved at the study end point	16 weeks

Secondary

Measure	Time frame
The proportion of patients in whom BP control was reached before the addition of HCTZ (ie, at the pre-HCTZ end point	8 weeks
Percentage of patients achieving overall BP, DBP, an SBP control rate at week 4, 8, 12 and 16.	16 weeks
Change in msSPA and msDBP from baseline to different time points	4,8,12 and 16 weeks
Safety of Aliskiren therapy at different time points	4,8,12 and 16 weeks

Countries

Venezuela

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026